Chemotherapy for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Endometrial CancerChemotherapy - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is for endometrial cancer patients with different molecular profiles. They will be assigned to different trials based on their profile and will receive different adjuvant therapies.

Eligible Conditions
  • Endometrial Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: 3 years, 5 years

3 years
MMRd-GREEN trial
NSMP-ORANGE trial
POLEmut-BLUE trial
p53abn-RED trial
3 years, 5 years
Endometrial cancer-specific survival
Health-related quality of life - Assessed using the EORTC QLQ-C30 questionnaire
Health-related quality of life - Assessed using the EORTC QLQ-EN24 questionnaire
Overall survival
Treatment-related toxicity - according to CTCAE v5.0
Vaginal recurrence-free survival
5 years
Pelvic recurrence-free survival
Recurrence-free survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Erlotinib-Chemotherapy
29%Nausea
19%Leukopenia
14%Vomiting
14%Neutropenia
14%Alanine aminotransferase increased
14%Thrombocytopenia
14%Anaemia
14%White blood cell count decreased
10%Aspartate aminotransferase increased
10%Platelet count decreased
10%Neutrophil count decreased
5%Musculoskeletal pain
5%Diarrhea
5%Dizziness
5%Back pain
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT02000531) in the Erlotinib-Chemotherapy ARM group. Side effects include: Nausea with 29%, Leukopenia with 19%, Vomiting with 14%, Neutropenia with 14%, Alanine aminotransferase increased with 14%.

Trial Design

7 Treatment Groups

p53abn-RED trial: control
1 of 7
MMRd-GREEN trial: control
1 of 7
NSMP-ORANGE trial: control
1 of 7
NSMP-ORANGE trial: experimental
1 of 7
p53abn-RED trial: experimental
1 of 7
MMRd-GREEN trial: experimental
1 of 7
POLEmut-BLUE
1 of 7

Active Control

Experimental Treatment

1611 Total Participants · 7 Treatment Groups

Primary Treatment: Chemotherapy · No Placebo Group · Phase 2 & 3

NSMP-ORANGE trial: experimentalExperimental Group · 3 Interventions: Megestrol Acetate, Pelvic external beam radiotherapy, Medroxyprogesterone Acetate · Intervention Types: Drug, Radiation, Drug
p53abn-RED trial: experimentalExperimental Group · 3 Interventions: Pelvic external beam radiotherapy, Olaparib, Chemotherapy · Intervention Types: Radiation, Drug, Drug
MMRd-GREEN trial: experimentalExperimental Group · 2 Interventions: Durvalumab, Pelvic external beam radiotherapy · Intervention Types: Drug, Radiation
POLEmut-BLUEExperimental Group · 2 Interventions: Observation, Pelvic external beam radiotherapy · Intervention Types: Other, Radiation
p53abn-RED trial: controlActiveComparator Group · 2 Interventions: Pelvic external beam radiotherapy, Chemotherapy · Intervention Types: Radiation, Drug
MMRd-GREEN trial: control
Radiation
ActiveComparator Group · 1 Intervention: Pelvic external beam radiotherapy · Intervention Types: Radiation
NSMP-ORANGE trial: controlActiveComparator Group · 2 Interventions: Pelvic external beam radiotherapy, Chemotherapy · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3220
Megestrol Acetate
2007
Completed Phase 3
~540
Olaparib
2017
Completed Phase 4
~2090
Medroxyprogesterone Acetate
2017
Completed Early Phase 1
~50
Chemotherapy
2003
Completed Phase 4
~2910

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years, 5 years

Who is running the clinical trial?

Leiden University Medical center (sponsor MMRd-GREEN trial)UNKNOWN
AstraZenecaIndustry Sponsor
3,989 Previous Clinical Trials
91,526,223 Total Patients Enrolled
10 Trials studying Endometrial Cancer
1,901 Patients Enrolled for Endometrial Cancer
Institute Gustave Roussy (sponsor p53abn-RED trial)UNKNOWN
University College London (sponsor NSMP-ORANGE trial)UNKNOWN
Dutch Gynaecological Oncology GroupUNKNOWN
Comprehensive Cancer Centre The NetherlandsOTHER
14 Previous Clinical Trials
8,438 Total Patients Enrolled
2 Trials studying Endometrial Cancer
695 Patients Enrolled for Endometrial Cancer
Dutch Cancer SocietyOTHER
96 Previous Clinical Trials
66,699 Total Patients Enrolled
4 Trials studying Endometrial Cancer
1,342 Patients Enrolled for Endometrial Cancer
Canadian Clinical Trials Group (sponsor POLEmut-BLUE trial)UNKNOWN
Leiden University Medical CenterLead Sponsor
432 Previous Clinical Trials
428,457 Total Patients Enrolled
5 Trials studying Endometrial Cancer
1,671 Patients Enrolled for Endometrial Cancer
Cancer Research UK & UCL Cancer Trials CentreOTHER
2 Previous Clinical Trials
2,002 Total Patients Enrolled
Melanie E Powell, Md PhDPrincipal InvestigatorBarts Health NHS Trust, London, United Kingdom (NSMP-ORANGE trial)
Emma J Crosbie, Md PhDPrincipal InvestigatorSt Mary's Hospital, Manchester, United Kingdom (NSMP-ORANGE trial)
Kathy Han, Md PhDPrincipal InvestigatorPrincess Margaret Cancer Centre, University of Toronto, Toronto, Canada (POLEmut-BLUE trial)
Judith R Kroep, MD PhDPrincipal InvestigatorLeiden University Medical Center, Leiden, The Netherlands (MMRd-GREEN trial)
3 Previous Clinical Trials
400 Total Patients Enrolled
Alexandra Leary, Md PhDPrincipal InvestigatorInstitute Gustave Roussy, Villejuif, France (p53abn-RED trial)
Jessica N McAlpine, Md PhDPrincipal InvestigatorUniversity of British Columbia,Vancouver, Canada (POLEmut-BLUE trial)

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

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References